Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China) (VIV)

Beijing Balance Medical Technology Co., Ltd

Status: Completed

Conditions: Bioprosthesis Failure

Treatments: Procedure: Transcatheter valve in Valve implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07174531

BRYL2020A

Details and patient eligibility

About

The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. A new bioprosthetic valve is delivered via a transcatheter approach and positioned inside the failing valve, restoring valve function .

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
2. Estimated high surgical risk (STS predicted risk of mortality ≥ 8 %) or formal contraindication to redo surgical as confirmed by an independent multidisciplinary heart-team review.

Exclusion criteria

1. Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
2. Failed mitral bioprosthesis with estimated post-procedural left-ventricular outflow tract obstruction (LVOTO) gradient ≥ 30 mmHg or LVOTO risk classified as "high" by the independent heart-team.
3. Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure > 60 mmHg).
4. Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
5. More than trivial paravalvular leak around the failing bioprosthesis.
6. Intracardiac thrombus, mass, or vegetation documented by imaging.
7. Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening.
8. Significant coronary artery disease mandating revascularization.
9. Active infective endocarditis within 6 months of screening.
10. Active infection requiring systemic antibiotic therapy at the time of screening.
11. Life expectancy < 12 months for any non-cardiac condition.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Prosthesis Failure Valve Replacement

Experimental group

Description:

Transcatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement.

Treatment:

Procedure: Transcatheter valve in Valve implantation